Risk Management is central to design of Medical Devices but most manufacturers do not have a robust and systematic approach.
Risk Management is the foundation for design of any medical device and the greatest risk is the unknown risk
Patients are generally unaware of the extent of responsibility of the device manufacturers and for this reason they either do not report device failures or do not follow it up to its ultimate conclusion.
Manufacturers generally employ individuals who are less qualified and experienced in order to reduce their manpower costs and ensure subdued teams who can be managed easily.